NCT00002243已完成1 期
A Phase 1B Dose-Range Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
Sarawak MediChem Pharmaceuticals17 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.
详细描述
Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You may be eligible for this study if you:
- •Are HIV-positive.
- •Have a CD4 count of at least 250 cells/mm
- •Have an HIV count (viral load) of at least 5,000 copies/ml.
- •Are at least 18 years old.
排除标准
- •You will not be eligible for this study if you:
- •Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study.
- •Have ever received anti-HIV medications.
- •Test positive for hepatitis B.
- •Have received a blood (or red blood cell) transfusion within 3 months prior to study entry.
- •Have severe diarrhea.
- •Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease.
- •Have hemophilia or another blood disorder.
- •Have received certain medications or vaccines within 30 days prior to study entry.
- •Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.
研究者
研究点 (17)
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